510(k) K910088
K910088 is an FDA 510(k) premarket notification submitted by Scitech Industries Partnership for the device "SCITECH BI-MANUAL ADAPTER CLIPS". The FDA issued a decision of Substantially Equivalent on April 8, 1991. The device falls under product code HQQ (Apparatus, Cautery, Radiofrequency, Battery-Powered), a Class II device regulated under 21 CFR 886.4100.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1991
- Date Received
- January 9, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Cautery, Radiofrequency, Battery-Powered
- Device Class
- Class II
- Regulation Number
- 886.4100
- Review Panel
- OP
- Submission Type